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van CCT (UK)

van CCT (UK)

ChIP-Studie: Changing Interpretations in PTSD

- candidate number16121
- NTR NumberNTR4405
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2014
- Secondary IDsNL45594.091.13 Commissie Mensgebonden Onderzoek regio Arnhem – Nijmegen (UMC St Radboud)
- Public TitleChIP-Studie: Changing Interpretations in PTSD
- Scientific TitleCognitive Bias Modification in Posttraumatic Stress Disorder: Training Positive Appraisal Style.
- ACRONYMChIP (Changing Interpretations in PTSD)
- hypothesisWe hypothesize that an appraisal- specific, computerized CBM training (referred to as CBM-app) can induce positive appraisal styles in a sample of PTSD patients. We expect that, compared to participants who receive a neutral training, those who receive positive CBM-app training will show less PTSD related dysfunctional cognitions/symptoms post training.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD)
- Inclusion criteria1. Between 18 en 70 years of age 2. Diagnosis of PTSD (structured interview MINI) 3. Self reported PTSD symptoms (PSS-SR > 20) 4. History of interpersonal trauma 5. Internet access and desktop computer
- Exclusion criteria1. Psychosis or delusion disorders (current/past) 2. Suicidality 3. Mental retardation 4. Substance/alcohol abuse or dependence 5. Insufficient ability to speak and write Dutch
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-feb-2014
- planned closingdate31-dec-2015
- Target number of participants146
- InterventionsInterpretation bias modification (CBM-app): This training comprises processing a series of reappraisal-related scripted vignettes (40 sentences per training session, 4 training sessions in total) that appear to participants as a sentence completion task. Each sentence comprises one to-be-completed word fragment, such that the meaning of the sentence remains ambiguous until the final word fragment is resolved. Positive training group: The word fragments produce an outcome consistent with positive (re) appraisal by assigning a positive meaning to the sentence. Neutral training group: The word fragments produce an outcome consistent with ambiguous (re) appraisal, as the meaning of the sentence will remain ambiguous.
- Primary outcome1. Appraisal Index (pre to post training). The “Appraisal Index” measures positive interpretation style in PTSD patients. It is calculated by summing up the number of PTSD-related appraisals in response to an open-ended ambiguous sentence task. A higher score on this “Appraisal Index” represents a more dysfunctional, PTSD-related interpretation style. 2. Post Traumatic Cognition Inventory (PTCI, pre to post training).
- Secondary outcome1. Interpretation bias as assessed with the Word Sentence Association Paradigm (WSAP). 2. Posttraumatic Stress Symptom Scale, Self Report (PSS-SR) (Foa, et al., 1993). 3. Frequency and amount of distress provoked by the most important, trauma-related re-experience in the preceding week 4. Trauma characteristics: Negative Life Events and Trauma Questionnaire (NLETQ). 5. Trauma-related psychopathology: Health Status as measured with EuroQol (EQ-5d). Depression as measured by Beck Depression Inventory (BDI). 6. Personality: Symptoms of borderline personality disorder, as measured by the Borderline Personality Disorder Checklist (BPD). Self-compassion as measured by a short-form version of the Self-Compassion Scale Short Form (SCS-SF) Explicit self-esteem, as assessed with the Rosenberg Self-Esteem Scale (RSES) 7. Implicit measures: Implicit self-esteem as assessed with an Implicit Association Test (IAT). Implicit trauma-identification as assessed with an Implicit Association Test (IAT). 8. The development of "Appraisal Index" and "Frequency/amount of distress of most important re-experience": Assessment before/after each training session. 9. The influence of CBM-app training on course of PTSD over a six months follow-up period. 10. Success of treatment as usual following the study.
- TimepointsPrimary outcome measures: 1. Appraisal Index (pre to post training). 2. PTCI (pre to post training). Secondary outcome measures: 1. WSAP (pre to post). 2. PSS-SR (pre to post). 3. Frequency/Distress re-experience (pre to post). 4. Trauma characteristics (pre). 5. Trauma-related psychopathology (pre to post). 6. Personality (pre). 7. Implicit measures (pre). 8. Development of Appraisal Index (before and after each training session). Development of Frequency/ amount of distress of most important re-experience (before each training session) 9. Outcomes on 1 month and 6 month follow up: Appraisal Index, PTCI, PSS-SR, Frequency/Distress re-experience, EQ-5d, BDI 10. Success of treatment as usual (follow up)
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT for SCIENTIFIC QUERIESProf. dr A. Minnen, van
- Sponsor/Initiator ProPersona/Overwaal
- Funding
(Source(s) of Monetary or Material Support)
Pro Persona/Overwaal
- Publications
- Brief summaryIn this randomized clinical trial, we want to examine whether a CBM training aimed at inducing positive appraisal style (positive CBM-app) can alter dysfunctional appraisal styles in PTSD patients. We will investigate the effects of CBM-app training on PTSD related dysfunctional cognitions and PTSD symptoms. Country of Recruitment: The Netherlands
- Main changes (audit trail)
- RECORD21-jan-2014 - 3-nov-2016

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